FDA.reportPublic FDA data

ESPINER TISSUE RETRIEVAL SYSTEM

Primary DI
05060358121876
Brand
ESPINER TISSUE RETRIEVAL SYSTEM
Company
ESPINER MEDICAL LIMITED
Model
EMP140ECO-US
Device description
Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111845000THE ESPINER SAC OR E SACEspiner Medical Limited2011-09-26GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
5060358120336PackageGS110In Commercial Distribution
05060358121876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5060358120336050603581203365060358120336
05060358121876050603581218765060358121876

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume550Milliliter

Contacts#

Phone, Email table
PhoneEmail
1-508-3848490bbarrett@globalmedllc.com

Regulatory Flags#

DUNS number
774603880
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060358121579ESPINER TISSUE RETRIEVAL SYSTEMEMP200ECO-R-102023-05-15
05060358121609ESPINER TISSUE RETRIEVAL SYSTEMEMP50ECO-R2016-09-23
05060358121616ESPINER TISSUE RETRIEVAL SYSTEMEMP70ECO2016-09-23
05060358121623ESPINER TISSUE RETRIEVAL SYSTEMEMP70ECO-S2016-09-23
05060358121630ESPINER TISSUE RETRIEVAL SYSTEMEMP95ECO2016-09-23
05060358121647ESPINER TISSUE RETRIEVAL SYSTEMEMP100ECO2016-09-23
05060358121654ESPINER TISSUE RETRIEVAL SYSTEMEMP100ECO-S2016-09-23
05060358121661ESPINER TISSUE RETRIEVAL SYSTEMEMP110ECO-R2016-09-23
05060358121678ESPINER TISSUE RETRIEVAL SYSTEMEMP140ECO2016-09-23
05060358121685ESPINER TISSUE RETRIEVAL SYSTEMEMP140ECO-S2016-09-23
05060358121692ESPINER TISSUE RETRIEVAL SYSTEMEMP145ECO2016-09-23
05060358121708ESPINER TISSUE RETRIEVAL SYSTEMEMP160ECO-S2016-09-23
05060358121715ESPINER TISSUE RETRIEVAL SYSTEMEMP170ECO2016-09-23
05060358121722ESPINER TISSUE RETRIEVAL SYSTEMEMP175ECO-W2016-09-23
05060358121739ESPINER TISSUE RETRIEVAL SYSTEMEMP180ECO2016-09-23
05060358121746ESPINER TISSUE RETRIEVAL SYSTEMEMP200ECO2016-09-23
05060358121753ESPINER TISSUE RETRIEVAL SYSTEMEMP230ECO2016-09-23
05060358121760ESPINER TISSUE RETRIEVAL SYSTEMEMP240ECO-S2016-09-23
05060358121777ESPINER TISSUE RETRIEVAL SYSTEMEMP600ECO2016-09-23
05060358121784ESPINER TISSUE RETRIEVAL SYSTEMECO60GREEN2016-09-23

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